NCT01146964

Brief Summary

The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

June 2, 2010

Last Update Submit

January 2, 2014

Conditions

CataractPhacoemulsification

Keywords

Age related cataractPhacoemulsificationManual super small incision cataract surgery

Outcome Measures

Primary Outcomes (1)

  • Corneal endothelial cell loss

    3 months postoperatively

Secondary Outcomes (2)

  • postoperative astigmatism

    3 months postoperatively

  • visual acuity

    3 month postoperatively

Study Arms (2)

Phacoemulsification, Safety, Efficacy

EXPERIMENTAL
Procedure: Phacoemulsification

MSSICS, Safety, Efficacy

EXPERIMENTAL
Procedure: MSSICS

Interventions

MSSICSPROCEDURE

Manual super small incision cataract surgery

MSSICS, Safety, Efficacy
PhacoemulsificationPROCEDURE

cataract surgery with Phacoemulsification

Phacoemulsification, Safety, Efficacy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age related cataract patients
  • Cataract density grade II-III according to the Emery-Little system classification system

You may not qualify if:

  • Legal guardian(s) is/are not present for permission
  • Other eye diseases impairing visual acuity (ie. glaucoma)
  • patients with severe systemic diseases not good for ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Wei Chen, MD, PhD

    Eye Hospital, Wenzhou Medical College, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 22, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

CN(1)